Capricor Therapeutics investors face a Sept. 28, 2026, deadline to seek lead plaintiff appointment in a securities class action covering purchases from Dec. 17, 2025, through July 26, 2026. The litigation alleges that Capricor and certain executives made misleading statements about Deramiocel and changed the HOPE-3 statistical analysis plan without FDA agreement before resubmitting the Biologics License Application. The FDA later said the Phase 3 study did not meet its prespecified primary and secondary efficacy endpoints at 12 months, while an advisory committee voted 9-3 against the drug's efficacy. Capricor shares fell 64% on July 27, 2026, to close at $7, with the complaint describing an aggregate decline of approximately 78.7% from a class-period high of $35.34 to $4.19 across two corrective disclosures. Separately, the FDA extended its PDUFA target action date for Deramiocel from Aug. 22 to Nov. 22, 2026, after classifying Capricor's submission, which included 24-month open-label extension data and a proposed focus on upper-limb function, as a major amendment.